NUMOTIZINE

Product NDC: 10546-100
11-digit product format: 105460100
Labeler code: 10546
Product ID: 10546-100_082b1721-9122-222f-e063-6294a90a5ea7
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Hobart Laboratories, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-11-30
Substance: MENTHOL
Active strength: 1.25 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: NUMOTIZINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1233196	Internal RxNorm lookup
1233201	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9a29ad1b-4ba3-403f-90c9-ee7582fe4535	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10546-100-08	NUMOTIZINE	228 g in 1 JAR	OINTMENT	228		8
10546-100-35	NUMOTIZINE	99 g in 1 JAR	OINTMENT	99		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
CREOSOL	INACTIVE INGREDIENT	W9GW1KZG6N	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
GUAIACOL	INACTIVE INGREDIENT	6JKA7MAH9C	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10546-100	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20231021_9a29ad1b-4ba3-403f-90c9-ee7582fe4535.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 131 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Feminine Anti-itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	19fe7c3b-58e2-6c16-e063-6394a90a612a	2024-06-03	Warnings	Exact identifier application number: M017
THE SOLUTION NUMBING	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	184be4cc-b0b9-7882-e063-6394a90a8e7e	2024-05-25	Warnings	Exact identifier application number: M017
Methyl Salicylate 25 Percent	METHYL SALICYLATE	Alexso, Inc	d8b8b0ba-69e9-4965-bf9b-6db21db69b34	2024-05-23	Warnings	Exact identifier application number: M017
Meijer Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Meijer Distribution	07ecc6a7-bbe3-35cf-e063-6394a90a2180	2024-05-22	Warnings	Exact identifier application number: M017
TheraCare Hydrocortisone Cream	HYDROCORTISONE	Veridian Healthcare	01cb7b47-2c3c-707d-e063-6294a90a5d97	2024-05-21	Warnings	Exact identifier application number: M017
TheraCare 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	c808aa05-9d49-cc9f-e053-2a95a90a50f3	2024-05-21	Warnings	Exact identifier application number: M017
TheraCare 4% Lidocaine and 1% Menthol Cream	MENTHOL AND LIDOCAINE	Veridian Healthcare	c80ba251-91a5-0858-e053-2995a90a9cff	2024-05-21	Warnings	Exact identifier application number: M017
HealthWise Menthol Roll-On	MENTHOL	Veridian Healthcare	102d57a5-6449-f825-e063-6294a90a8844	2024-05-21	Warnings	Exact identifier application number: M017
SAFLY Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	3aca2568-d10f-4b14-861b-6c741c106829	2024-05-17	Warnings	Exact identifier application number: M017
HealthWise Menthol 4% Roll-On	MENTHOL	Veridian Healthcare	1894ef00-ba05-0e02-e063-6394a90ab982	2024-05-16	Warnings	Exact identifier application number: M017
Leader Poison Ivy Wash	PRAMOXINE HYDROCHLORIDE LOTION	Cardinal Health, 110 dba Leader	81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c	2024-05-13	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1233196	menthol 1.25 % Topical Ointment	PSN	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	NUMOTIZINE 1.25 % Topical Ointment	PSN	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	menthol 0.0125 MG/MG Topical Ointment [Numotizine]	SBD	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233196	menthol 0.0125 MG/MG Topical Ointment	SCD	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	Numotizine 0.0125 MG/MG Topical Ointment	SY	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	Numotizine 1.25 % Topical Ointment	SY	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10546-100-08	10546010008	228 g in 1 JAR (10546-100-08)	228 g	2011-11-30	0000-00-00	No	No	Current
10546-100-35	10546010035	99 g in 1 JAR (10546-100-35)	99 g	2011-11-30	0000-00-00	No	No	Current